NCT04423757

A Home-based Study Using Mobile Technology to Test Whether BI 1358894 is Effective in People With Depression

A Phase II 6-week, Randomized, Double-blinded, Placebo Controlled, Parallel Group Decentralised Clinical Trial to Evaluate Efficacy and Safety of Oral BI 1358894 in Patients With Major Depressive Disorder With Inadequate Response to Antidepressants

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a home-based study in adults with depression. People who have been diagnosed with Major Depressive Disorder can participate in the study. Participants can take part if they are being treated for their depression but still have symptoms. The purpose of this study is to find out whether a medicine called BI 1358894 helps people with depression. Participants are in the study for about 2 months and do not need to visit a study site during this time. All study visits are conducted at participant's home by a mobile study nurse, by videoconference, and by phone calls. Participants are put into 2 groups by chance. One group takes BI 1358894 tablets. The other group takes placebo tablets. Placebo tablets look like BI 1358894 tablets but do not contain any medicine. The participants answer questions about the symptoms of their depression. We then compare the results between the BI 1358894 and placebo groups. The doctors and nurses also regularly check the general health of the participants.

Conditions

• Depressive Disorder, Major

Interventions

Type	Name	Description
DRUG	BI 1358894	125 milligram (mg) BI 1358894 taken orally as three film-coated tablets (1x 25mg and 2x 50mg) once a day in the morning for six weeks.
DRUG	Placebo	Placebo matching BI 1358894 taken orally as three film-coated tablets once a day in the morning for six weeks.

Timeline

• Start date: 2020-06-22
• Primary completion: 2022-04-19
• Completion: 2022-05-08
• First posted: 2020-06-09
• Last updated: 2023-06-13
• Results posted: 2023-05-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study